{
  "topic": {
    "stem": "LIGELIZUMAB_URTICARIA_AUTO_2",
    "name": "Ligelizumab in CSU (broader)",
    "ncts": [
      "NCT03580369",
      "NCT03907878",
      "NCT03580356",
      "NCT05024058",
      "NCT04210843",
      "NCT03437278",
      "NCT02649218",
      "NCT04513548"
    ],
    "drug_patterns": [
      "ligelizumab"
    ],
    "condition_patterns": [
      "urticaria"
    ]
  },
  "trials": [
    {
      "gates": {
        "A_aact_exists": true,
        "B_drug_in_intvs": true,
        "C_condition_in_aact": true,
        "D_pmid_topic_match": true,
        "E_two_arms": true,
        "F_primary_outcome_known": true
      },
      "extracted": {
        "nct": "NCT03580369",
        "aact_title": "A Phase III Study of Safety and Efficacy of Ligelizumab in the Treatment of CSU in Adolescents and Adults Inadequately Controlled With H1-antihistamines",
        "aact_acronym": "",
        "start_date": "2018-10-17",
        "primary_completion_date": "2021-07-16",
        "aact_intvs": [
          "ligelizumab",
          "omalizumab",
          "placebo"
        ],
        "aact_conditions": [
          "chronic spontaneous urticaria"
        ],
        "pmid": "38008109",
        "pubmed_year": 2024,
        "pubmed_doi": "10.1016/S0140-6736(23)01684-7",
        "aact_per_arm_counts": {
          "BG000": 317,
          "BG001": 324,
          "BG002": 322,
          "BG003": 109
        },
        "aact_primary_outcome_measure": "Mean Change From Baseline in UAS7 at Week 12 (Multiple Imputation) of Adult Subjects",
        "aact_outcome_count_rows": [
          [
            "OG001",
            "150.0"
          ],
          [
            "OG002",
            "147.0"
          ],
          [
            "OG000",
            "102.0"
          ],
          [
            "OG001",
            "104.0"
          ],
          [
            "OG002",
            "116.0"
          ],
          [
            "OG003",
            "8.0"
          ],
          [
            "OG000",
            "3.0"
          ],
          [
            "OG001",
            "3.0"
          ],
          [
            "OG002",
            "0.0"
          ],
          [
            "OG003",
            "1.0"
          ]
        ]
      }
    },
    {
      "gates": {
        "A_aact_exists": true,
        "B_drug_in_intvs": true,
        "C_condition_in_aact": true,
        "D_pmid_topic_match": false,
        "E_two_arms": false,
        "F_primary_outcome_known": true
      },
      "extracted": {
        "nct": "NCT03907878",
        "aact_title": "A Safety and Efficacy Study of Ligelizumab in the Treatment of CSU in Japanese Patients Inadequately Controlled With H1- Antihistamines",
        "aact_acronym": "",
        "start_date": "2019-04-13",
        "primary_completion_date": "2022-01-26",
        "aact_intvs": [
          "ligelizumab"
        ],
        "aact_conditions": [
          "chronic spontaneous urticaria"
        ],
        "pmid": null,
        "aact_per_arm_counts": {
          "BG000": 66
        },
        "aact_primary_outcome_measure": "Safety and Tolerability of Ligelizumab 120 mg q4w Treatment for 12 Months",
        "aact_outcome_count_rows": [
          [
            "OG000",
            "53.0"
          ],
          [
            "OG000",
            "11.0"
          ],
          [
            "OG000",
            "0.0"
          ],
          [
            "OG000",
            "13.0"
          ],
          [
            "OG000",
            "0.0"
          ],
          [
            "OG000",
            "0.0"
          ],
          [
            "OG000",
            "4.0"
          ],
          [
            "OG000",
            "0.0"
          ],
          [
            "OG000",
            "14.0"
          ],
          [
            "OG000",
            "26.0"
          ]
        ]
      }
    },
    {
      "gates": {
        "A_aact_exists": true,
        "B_drug_in_intvs": true,
        "C_condition_in_aact": true,
        "D_pmid_topic_match": true,
        "E_two_arms": true,
        "F_primary_outcome_known": true
      },
      "extracted": {
        "nct": "NCT03580356",
        "aact_title": "A Phase III Study of and Efficacy of Ligelizumab in the Treatment of CSU in Adolescents and Adults Inadequately Controlled With H1-antihistamines.",
        "aact_acronym": "",
        "start_date": "2018-10-20",
        "primary_completion_date": "2021-06-22",
        "aact_intvs": [
          "ligelizumab",
          "omalizumab",
          "placebo"
        ],
        "aact_conditions": [
          "chronic spontaneous urticaria"
        ],
        "pmid": "38008109",
        "pubmed_year": 2024,
        "pubmed_doi": "10.1016/S0140-6736(23)01684-7",
        "aact_per_arm_counts": {
          "BG000": 323,
          "BG001": 323,
          "BG002": 323,
          "BG003": 109
        },
        "aact_primary_outcome_measure": "Mean Change From Baseline in UAS7 at Week 12 (Multiple Imputation) of Adult Subjects",
        "aact_outcome_count_rows": [
          [
            "OG000",
            "88.0"
          ],
          [
            "OG001",
            "103.0"
          ],
          [
            "OG002",
            "94.0"
          ],
          [
            "OG003",
            "4.0"
          ],
          [
            "OG000",
            "4.0"
          ],
          [
            "OG001",
            "8.0"
          ],
          [
            "OG002",
            "5.0"
          ],
          [
            "OG003",
            "0.0"
          ],
          [
            "OG000",
            "134.0"
          ],
          [
            "OG001",
            "153.0"
          ]
        ]
      }
    },
    {
      "gates": {
        "A_aact_exists": true,
        "B_drug_in_intvs": true,
        "C_condition_in_aact": true,
        "D_pmid_topic_match": false,
        "E_two_arms": true,
        "F_primary_outcome_known": true
      },
      "extracted": {
        "nct": "NCT05024058",
        "aact_title": "Study of Efficacy and Safety of Ligelizumab in Adolescents and Adults With Chronic Inducible Urticaria Who Remain Symptomatic Despite Treatment With H1- Antihistamines",
        "aact_acronym": "PEARL-PROVOKE",
        "start_date": "2021-11-16",
        "primary_completion_date": "2022-08-09",
        "aact_intvs": [
          "ligelizumab",
          "placebo"
        ],
        "aact_conditions": [
          "chronic inducible urticaria"
        ],
        "pmid": null,
        "aact_per_arm_counts": {
          "BG000": 5,
          "BG001": 6,
          "BG002": 4,
          "BG003": 2,
          "BG004": 3,
          "BG005": 3,
          "BG006": 1,
          "BG007": 3,
          "BG008": 6,
          "BG009": 6
        },
        "aact_primary_outcome_measure": "Change From Baseline in Total Fric Score in Participants With Symptomatic Dermographism",
        "aact_outcome_count_rows": [
          [
            "OG000",
            "-26.0"
          ],
          [
            "OG001",
            "-15.0"
          ],
          [
            "OG000",
            "-7.0"
          ],
          [
            "OG000",
            "1.0"
          ],
          [
            "OG001",
            "0.0"
          ],
          [
            "OG000",
            "-9.0"
          ],
          [
            "OG001",
            "0.0"
          ],
          [
            "OG000",
            "0.0"
          ],
          [
            "OG001",
            "0.0"
          ],
          [
            "OG000",
            "0.0"
          ]
        ]
      }
    },
    {
      "gates": {
        "A_aact_exists": true,
        "B_drug_in_intvs": true,
        "C_condition_in_aact": true,
        "D_pmid_topic_match": false,
        "E_two_arms": true,
        "F_primary_outcome_known": true
      },
      "extracted": {
        "nct": "NCT04210843",
        "aact_title": "Study of Efficacy and Safety of Ligelizumab in Chronic Spontaneous Urticaria Patients Who Completed a Previous Study With Ligelizumab",
        "aact_acronym": "",
        "start_date": "2020-04-08",
        "primary_completion_date": "2022-09-01",
        "aact_intvs": [
          "ligelizumab"
        ],
        "aact_conditions": [
          "chronic spontaneous urticaria"
        ],
        "pmid": null,
        "aact_per_arm_counts": {
          "BG000": 290,
          "BG001": 743
        },
        "aact_primary_outcome_measure": "Percentage of Subjects From Core Studies (CQGE031C2302 and CQGE031C2303), Receiving the Same Dose Regimen as in the Core Studies, With Well-controlled Disease (UAS7 ≤ 6) at Week 12",
        "aact_outcome_count_rows": [
          [
            "OG000",
            "53.5"
          ],
          [
            "OG001",
            "57.5"
          ],
          [
            "OG001",
            "55.8"
          ],
          [
            "OG000",
            "37.3"
          ],
          [
            "OG001",
            "41.5"
          ],
          [
            "OG000",
            "45.6"
          ],
          [
            "OG000",
            "69.4"
          ],
          [
            "OG001",
            "69.5"
          ],
          [
            "OG000",
            "81.9"
          ],
          [
            "OG001",
            "82.6"
          ]
        ]
      }
    },
    {
      "gates": {
        "A_aact_exists": true,
        "B_drug_in_intvs": true,
        "C_condition_in_aact": true,
        "D_pmid_topic_match": true,
        "E_two_arms": true,
        "F_primary_outcome_known": true
      },
      "extracted": {
        "nct": "NCT03437278",
        "aact_title": "Study to Investigate the Efficacy and Safety of QGE031 in Adolescent Patients With Chronic Spontaneous Urticaria (CSU)",
        "aact_acronym": "",
        "start_date": "2018-08-01",
        "primary_completion_date": "2020-10-23",
        "aact_intvs": [
          "ligelizumab",
          "placebo"
        ],
        "aact_conditions": [
          "chronic spontaneous urticaria"
        ],
        "pmid": "37492920",
        "pubmed_year": 2023,
        "pubmed_doi": "10.1111/pai.13982",
        "aact_per_arm_counts": {
          "BG000": 24,
          "BG001": 13,
          "BG002": 12
        },
        "aact_primary_outcome_measure": "Change From Baseline of Weekly Urticaria Activity Score (UAS7) at Week 24",
        "aact_outcome_count_rows": [
          [
            "OG000",
            "4.0"
          ],
          [
            "OG001",
            "5.0"
          ],
          [
            "OG002",
            "2.0"
          ],
          [
            "OG000",
            "8.0"
          ],
          [
            "OG001",
            "8.0"
          ],
          [
            "OG002",
            "4.0"
          ],
          [
            "OG000",
            "3.0"
          ],
          [
            "OG001",
            "2.0"
          ],
          [
            "OG002",
            "4.0"
          ],
          [
            "OG000",
            "4.0"
          ]
        ]
      }
    },
    {
      "gates": {
        "A_aact_exists": true,
        "B_drug_in_intvs": true,
        "C_condition_in_aact": true,
        "D_pmid_topic_match": true,
        "E_two_arms": false,
        "F_primary_outcome_known": true
      },
      "extracted": {
        "nct": "NCT02649218",
        "aact_title": "A Safety Extension Study to Evaluate the Long-term Safety of QGE031 in Chronic Spontaneous Urticaria (CSU) Patients",
        "aact_acronym": "",
        "start_date": "2016-05-24",
        "primary_completion_date": "2019-05-02",
        "aact_intvs": [
          "ligelizumab"
        ],
        "aact_conditions": [
          "chronic spontaneous urticaria"
        ],
        "pmid": "36440464",
        "pubmed_year": 2022,
        "pubmed_doi": "10.1016/j.waojou.2022.100716",
        "aact_per_arm_counts": {
          "BG000": 226
        },
        "aact_primary_outcome_measure": "Number of Participants With at Least One Treatment Emergent Adverse Event (AE)",
        "aact_outcome_count_rows": [
          [
            "OG000",
            "190.0"
          ],
          [
            "OG000",
            "0.44"
          ],
          [
            "OG000",
            "61.06"
          ],
          [
            "OG000",
            "28.32"
          ],
          [
            "OG000",
            "1.0"
          ],
          [
            "OG000",
            "138.0"
          ],
          [
            "OG000",
            "64.0"
          ]
        ]
      }
    },
    {
      "gates": {
        "A_aact_exists": true,
        "B_drug_in_intvs": true,
        "C_condition_in_aact": true,
        "D_pmid_topic_match": false,
        "E_two_arms": false,
        "F_primary_outcome_known": true
      },
      "extracted": {
        "nct": "NCT04513548",
        "aact_title": "Study of Mechanism of Action of Ligelizumab (QGE031) in Patients With Chronic Urticaria",
        "aact_acronym": "MASTER",
        "start_date": "2020-08-05",
        "primary_completion_date": "2022-07-19",
        "aact_intvs": [
          "ligelizumab",
          "placebo"
        ],
        "aact_conditions": [
          "cholinergic urticaria",
          "chronic spontaneous urticaria",
          "cold urticaria"
        ],
        "pmid": null,
        "aact_per_arm_counts": {},
        "aact_primary_outcome_measure": "Part 1: Wheal and erythema size after skin prick test with several different ciprofloxacin and icatibant concentrations.",
        "aact_outcome_count_rows": []
      }
    }
  ],
  "n_total": 8,
  "n_pass_all": 3,
  "verdict": "VIABLE",
  "pass_rate": 0.375
}